CN1049114C - Method for prepn. of slowly-released medicaments preparation - Google Patents
Method for prepn. of slowly-released medicaments preparation Download PDFInfo
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- CN1049114C CN1049114C CN95113357A CN95113357A CN1049114C CN 1049114 C CN1049114 C CN 1049114C CN 95113357 A CN95113357 A CN 95113357A CN 95113357 A CN95113357 A CN 95113357A CN 1049114 C CN1049114 C CN 1049114C
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- cellulose
- pharmaceutic adjuvant
- slow releasing
- hydroxypropyl
- nifedipine
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Abstract
The present invention relates to a method for preparing slowly-released tablets containing medicines with curative activity and unreactive components, which comprises the steps that at least one medicine with curative activity, such as nifedipine, and at least one unreactive component, such as hydroxypropyl cellulose are granulated; the obtained particles are micronized. The rest unreactive components can be independently granulated and mixed with the particles, or mixed with the particles and then granulated. A lubricating agent is added for processing; enough granulating liquid for promoting granulation is added and tablets are obtained through pressing. The method is simple and only needs conventional equipment. The obtained product has the advantages of consistent release mode, good content uniformity and good bioavailability.
Description
The invention relates to the method that preparation contains the slow releasing tablet of therapeutic activity component.Furtherly, the present invention is the method that a kind of new preparation contains active constituent and nonactive component particles, and this microgranule can be used in the prescription of slow releasing tablet.
No matter concerning patient, perhaps concerning the doctor, slow release formulation generally has bigger advantage than general formulation.Because it can (only need take medicine once in one) sometimes, just can in the long time, supply with the active constituent of effective therapeutic dose continuously under the less situation of medicining times.
Giving solid drugs is to give the active constituent coating with insoluble relatively coating material with the common approaches of slow release characteristics, or active constituent is embedded in the peucinous matrix tablet.The slow diffusion or the corrosion of coated tablet or matrix tablet just disengage active constituent.Put down in writing many such methods in the patent documentation, for example:
United States Patent (USP) 4666705 has been described a kind of controlled release drug tablet that contains a kind of active agents and a kind of acrylate copolymer or copolymer.This tablet is made with the dry granulation technology, need not coating.
United States Patent (USP) 4786503 has been described a kind of medicinal tablet type that is made of two kinds of thin layers adjacent one another are.This thin layer can contain active constituent and nonactive component, controls the release characteristics of tablet with the arrangement of thin layer.Each thin layer is made of at least a hydroxypropyl emthylcellulose.The different degree of polymerization (DE value) of cellulose also can be used to control the release of active constituent.United States Patent (USP) 4814175 has been described the combination drug that contains mepindolol and nifedipine (nifedipine).Use conventional excipients, mepindolol and nifedipine (nifedipine) are granulated respectively with wet method or dry granulation technology.Then they are packed in the hard capsule together, be used for oral.
United States Patent (USP) 4882144 and heavily issue patent RE33963 and United States Patent (USP) 5264446 has been described a kind of solid medicament formulations and preparation technology thereof who contains dihydropyridine.Described especially that wherein nifedipine and polyvinyl pyrrole Lip river alkane ketone are dissolved in the limited amount organic solvent to form a kind of heavy-gravity fat, again this fat with intersect associating, insoluble polyvinyl pyrrole Lip river alkane ketone mixes, and makes its cohesionization.The mixture tabletting of this cohesionization, nifedipine wherein (or other dihydropyridine active agents) is distributed evenly in the tablet.
United States Patent (USP) 5266581 has been described other and has been contained the pharmaceutical formulation of dihydropyridine, polyvinyl pyrrole Lip river alkane ketone.Earlier dihydropyridine, polyvinyl pyrrole Lip river alkane ketone are dissolved in the suitable organic solvent, add wetting agent then; Add insoluble polyvinyl pyrrole Lip river alkane ketone again in mixture, granulate.Formed granule adds various conventional additives again, makes tablet.
United States Patent (USP) 4952402 has been described a kind of edible and medicinal controlled release power formulations.This prescription comprises the microgranule of pre-sizing (0.1-125 micron) as skeletal matrix, and this microgranule is made by the inert polymer that wherein is uniform-distribution with active constituent.The rate of dissolution of inert polymer skeletal matrix produces the release that delays of active constituent.
United States Patent (USP) 5108757 has been described and United States Patent (USP) 5266581 similar a kind of processes, but not that handle contains insoluble polyvinyl pyrrole Lip river alkane ketone and nifedipine/polyvinyl pyrrole Lip river alkane alcohol/ketone mixtures is directly granulated, but after in nifedipine/polyvinyl pyrrole Lip river alkane ketone fat, adding wetting agent, sustained-release agent, again this fat coating is made into inertia delivery granule.The delivery particle drying that coating is crossed, sieve.Coated granule mixes with conventional additives, perhaps tabletting, coating; Perhaps pack in the conventional capsule.The inventor declares: since in this technology active constituent without grinding, particulate size distribution of initiation material and structure to the release mode of tablet product without any influence.Yet it is to be noted: the size distribution of the delivery granule that coated active constituent is made itself and structure can cause fluctuation on some statistics to the release mode of tablet finished product.
Following patent literature has been described similar pharmaceutical formulation and process: Deutsche Bundespatent 2822882, Deutsche Bundespatent 3142853, European patent 47889, European patent 78430, Japan Patent 58-109482, British patent 2139892 etc.These patent documentations can be with above-mentioned american documentation literature reference.
The object of the present invention is to provide a kind of method, the active agents that certain is given is mixed with the tablet that delays to discharge that its active constituent has consistent release mode, good content uniformity and good bioavailability.
Purpose of the present invention also is to provide a kind of method, and nifedipine (Nifedipine) is mixed with the tablet that delays to discharge that its active constituent has consistent release mode, good content uniformity and good bioavailability.
Another object of the present invention is to provide a kind of simple, direct process, only need conventional equipment just can realize above-mentioned purpose.
Contain the method for the slow releasing tablet of therapeutic activity medicament by this preparation provided by the invention, comprise that preparation contains the microgranule of active agents and nonactive component, this microgranule can be used for making and has steadily and the tablet formulation that delays release mode.
Step of the present invention comprises:
One, will have the medicine of therapeutic activity such as nifedipine and at least a pharmaceutic adjuvant such as hydroxypropylcelluloether ether to mix, wet method prepares granule, drying; With this granule micronize, make the microgranule 1 of magnitude range again at the 1-50 micron;
Two, with other pharmaceutic adjuvant uniform mixing of microgranule 1 and slow releasing tablet, direct compression makes slow releasing tablet; If needed can be with the slow releasing tablet coating.
Perhaps,, take conventional wet granulation technology, make granule other pharmaceutic adjuvant uniform mixing of microgranule 1 and slow releasing tablet; The granulation liquid that wet granulation is used can adopt water, or adopts other hydration solvent, as the alcohol amount of containing is the alcohol-water solution of 5-50%; With the particle drying that makes; Pulverize; Can add suitable lubricant, be pressed into slow releasing tablet; If needed can be with the slow releasing tablet coating.
The tablet that makes like this has consistent release mode, good content uniformity and good bioavailability.
The particulate micronize of step 1 gained has guaranteed that the active constituent in the tablet finished product can distribute more equably.The influence that active constituent granular size difference is caused because micronize has overcome.For certain given active constituent, between the different suppliers or between the product of the different lot numbers of same supplier, its particulate size usually has very big difference with distribution.The particulate micronize of gained in the step 1 has been dwindled the influence that this species diversity causes, thereby makes the tablet finished product of making have extremely good content uniformity, consistent release mode and good bioavailability.
Nifedipine (Nifedipine), chemical name: 1,4-dihydro-2,6-dimethyl-4-(2-nitrobenzophenone)-3,5-dipicolinic acid dimethyl ester is a kind of human recycle system's of acting on the medicament with pharmacologically active, belongs to one of reactive compound member who is commonly called dihydropyridine.Because nifedipine is extremely sensitive to light, the utmost point is insoluble in water again, make it have good bioavailability, the tablet of good content uniformity and consistent release mode is very difficult.To producing the Nifedipine sustained release tablets agent that can successfully supply with effective therapeutic dose, method of the present invention is effective especially.
Below be being described in detail of the inventive method.
The step of a kind of implementation of the present invention is as follows:
One, will have the medicament of therapeutic activity such as nifedipine and nonactive component such as hydroxypropyl cellulose and granulate together, obtain first part of granule.Available any known method of granulating prepares this first part of granule.If necessary, with the gained particle drying.The method of available any routine such as fluidized bed dryer come dry.
Then with this first part of granule micronize, to obtain the particle of magnitude range at the 1-50 micron.Drop on the particle in this magnitude range, be commonly referred to as microgranule.Disintegrating apparatus such as grinder that available any merchant sells are finished micronize, and for example, such equipment can be bought to following company: The Jet Pulverizer Company, and Palmura, NJ 08065, so U.S.A. obtains microgranule 1.
Two, with other pharmaceutic adjuvant (powder or granule) mix homogeneously of microgranule 1 and slow releasing tablet, direct compression makes slow releasing tablet; If needed can be with the slow releasing tablet coating.
The step of another kind of implementation of the present invention is as follows:
One, will have medicament such as the nifedipine and the pharmaceutic adjuvant uniform mixing of therapeutic activity, granulate.If necessary, with the gained particle drying.Then with the granule micronize, to obtain the microgranule 1 of magnitude range at the 1-50 micron.Employed pharmaceutic adjuvant can selective polymerization cellulose ethers macromolecular compound or general pharmaceutic adjuvant in this step, as saccharide, starch based or polyvinyl pyrrole Lip river alkane ketone.
Two, with other pharmaceutic adjuvant mix homogeneously of microgranule 1 and slow releasing tablet, carry out secondary wet-granulation technology, make granule; The technology of producing tablet according to routine makes slow releasing tablet.If needed can be with the slow releasing tablet coating.
The active constituent that uses in the method for the present invention can comprise various organic or inorganic medicaments, and unrestricted.For example: active constituent can comprise various water solublity, half water solublity or the water-insoluble medicament that pharmacologically active is arranged, but this and unrestricted range of application of the present invention.
The quantity for preparing the nonactive component that first part of granule use can account for spendable suitable nonactive component, preferably cellulosic polymer in 4-99% this method of weight.Such cellulosic polymer comprises cellulose ether such as methylcellulose; Cellulose alkyl hydroxy chemical compound such as hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose or the like; Cellulose alkyl carboxyl chemical compound such as carboxymethyl cellulose and carboxyethyl cellulose.Can use in the described cellulosic polymer one or more.For example: 20 parts of 80 parts of nifedipines and hydroxypropyl celluloses; 20 parts of 80 parts of nifedipines and hydroxypropyl emthylcelluloses; 20 parts of 70 parts of nifedipines, hydroxypropyl emthylcellulose and 10 parts of hydroxypropyl celluloses etc.The specific surface area of used nifedipine should be less than 1 meters squared per gram.
Preparation microgranule 1 selectable pharmaceutic adjuvant also has additive of tablet commonly used such as starch, alginate, acrylate polymer, polyvinyl pyrrole Lip river alkane ketone, lactose, microcrystalline Cellulose, calcium salt and other saccharide etc.For example: 92 parts of nifedipines, 8 parts of polyvinyl pyrrole Lip river alkane ketone; Perhaps 70 parts of nifedipines, 8 parts of polyvinyl pyrrole Lip river alkane ketone, 22 parts of lactose; The specific surface area of used nifedipine should be less than 1 meters squared per gram.
In the step 2 of each implementation, other pharmaceutic adjuvant of the slow releasing tablet that is adopted should comprise excipient, lubricant and binding agent.
All pharmaceutic adjuvant when excipient should be included in preparation microgranule 1 in the step 1 of each implementation, for example: cellulosic polymer, alginate, acrylate polymer etc.
Spendable lubricant in this method comprises common various water-soluble or water-insoluble lubricant, preferably magnesium stearate or stearic acid.Can use one or more lubricants simultaneously.The consumption of lubricant should be enough to make tablet leniently to form.
In addition, also can use one or more binding agents enough, persistent mechanical strength to be arranged in this method to guarantee finished tablet.No matter in transit, when still (in pipe intestinal digesting liquid) is mobile in liquid stream, remain complete these binding agents guarantee the firm in structure of finished tablets, make them.Suitable adhesive has starch such as corn starch, modified corn starch; Polyvinyl pyrrole Lip river alkane ketone; Radix Acaciae senegalis or the like.
In addition, this method also can use routine to be used for the various edibility non-reactive additives of solid pharmaceutical preparation.These conventional nonactive components that use comprise: additives such as antiseptic, coloring agent, stabilizing agent, antitack agent, smoothing preparation, desiccant, diluent, stripping controlling agent.
Contain the method for the slow releasing tablet of therapeutic activity component by this preparation provided by the invention, compare, have simple, direct advantage, only need conventional equipment with existing method; Just can easily that certain is given active agents be mixed with the tablet that delays to discharge that its active constituent has consistent release mode, good content uniformity and good bioavailability; The composition range that the pharmacologically active effect is arranged that is suitable for is big; The special advantage of this method is: can some are extremely sensitive to light, the utmost point is insoluble in water again, generally be difficult to make the medicament component (for example nifedipine) of slow releasing tablet, make have good bioavailability, good content uniformity and consistent slow releasing tablet release mode, that can successfully supply with effective therapeutic dose.
Following embodiment can further specify method of the present invention, but and unrestricted range of application of the present invention.
Embodiment 1,
A kind of preparation contains the method for the slow releasing tablet of therapeutic activity medicament and nonactive component, comprises the following steps:
One, will have the medicament of therapeutic activity such as nifedipine and nonactive component such as hydroxypropyl cellulose and granulate together, obtain first part of granule.Available any known method of granulating prepares this first part of granule.If necessary, with the gained particle drying.The method of available any routine such as fluidized bed dryer come dry.
Then with this first part of granule micronize, to obtain the particle of magnitude range at the 1-50 micron.Disintegrating apparatus such as grinder that available any merchant sells are finished micronize, and for example, such equipment can be bought to following company: The Jet Pulverizer Company, and Palmura, NJ 08065, so U.S.A. obtains microgranule 1.
Two, with other pharmaceutic adjuvant uniform mixing of microgranule 1 and slow releasing tablet, be prepared into granule with any known method of granulating.If necessary, with gained particle drying and pulverizing.
Three, add additives such as lubricant in the granule that in by step 2, obtains, be pressed into slow releasing tablet; If needed can be with the slow releasing tablet coating.
Embodiment 2,
Press embodiment 1 described method, but step 2 wherein be with granule of the medicinal axle material of in the tablet formulation other or powder directly with microgranule 1 uniform mixing, and add additive such as lubricant, granulation together.Microgranule 1 does not carry out secondary and granulates.
Embodiment 3,
Press embodiment 1,2 described methods, but preparation during drug microparticles (step 1) add by water or to contain the alcohol amount be the granulation liquid that the alcohol aqueous solution of 5-50% is formed.
Embodiment 4,
Press embodiment 1,2,3 described methods, but described the medicament of therapeutic activity is arranged is nifedipine (nifedipine).
Embodiment 5,
Press embodiment 1,2,3,4 described methods, but the nonactive component (being pharmaceutic adjuvant) described in the step 1, step 2 can be in cellulose ether, cellulose alkyl hydroxy chemical compound, the cellulose alkyl carboxyl chemical compound any one or a few; Also can be polyvinyl pyrrole Lip river alkane ketone, starch and and derivant, microcrystalline Cellulose, lactose, calcium salt, alginate, acrylate polymer, saccharide etc. in any one or a few.
Embodiment 6,
Press embodiment 5 described methods, but described nonactive component can be in methylcellulose, hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, carboxymethyl cellulose and the carboxyethyl cellulose any one or a few.
Embodiment 7,
Press embodiment 6 described methods, but the mixture that described nonactive component is hydroxypropyl cellulose and hydroxypropyl emthylcellulose; In the step 1 with 20 parts of 70 parts of nifedipines, hydroxypropyl emthylcellulose with 10 parts of granulations of hydroxypropyl cellulose, obtain first part of granule.The specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 8,
Press embodiment 6 described methods, but described nonactive component is a hydroxypropyl cellulose; In the step 1 with 80 parts of nifedipines with 20 parts of granulations of hydroxypropyl cellulose, obtain first part of granule, the specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 9,
Press embodiment 6 described methods, but described nonactive component is a hydroxypropyl emthylcellulose; In the step 1 with 80 parts of nifedipines with 20 parts of granulations of hydroxypropyl emthylcellulose, obtain first part of granule, the specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 10,
Press embodiment 5 described methods, but described nonactive component is a polyvinyl pyrrole Lip river alkane ketone; In the step 1 with 96 parts of nifedipines with 4 parts of granulations of polyvinyl pyrrole Lip river alkane ketone, obtain first part of granule, the specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 11,
Press embodiment 5 described methods, but described nonactive component is polyvinyl pyrrole Lip river alkane ketone and starch; In the step 1 with 8 parts of 70 parts of nifedipines, polyvinyl pyrrole Lip river alkane ketone with 22 parts of granulations of starch, obtain first part of granule, the specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 12,
Press embodiment 5 described methods, but described nonactive component is polyvinyl pyrrole Lip river alkane ketone and lactose; In the step 1 with 8 parts of 70 parts of nifedipines, polyvinyl pyrrole Lip river alkane ketone with 22 parts of granulations of lactose, obtain first part of granule, the specific surface area of used nifedipine should be less than 1 meters squared per gram.
Embodiment 13,
Press embodiment 5 described methods, but the nonactive component described in the step 2 is the mixture of hydroxypropyl cellulose and hydroxypropyl emthylcellulose.
Embodiment 14,
Press embodiment 5 described methods, but the nonactive component described in the step 2 is a hydroxypropyl cellulose; Or hydroxypropyl emthylcellulose.
Embodiment 15,
Press embodiment 5 described methods, but the nonactive component described in the step 2 can be in methylcellulose, hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, carboxymethyl cellulose and the carboxyethyl cellulose any one or a few.
Claims (8)
1, a kind of preparation contains the method for the slow releasing tablet of nifedipine, it is characterized in that this method comprises the following steps:
One, specific surface area is mixed less than the nifedipine of 1 meters squared per gram and the pharmaceutic adjuvant that accounts for weight 4-99%, wet method prepares granule, drying: again with this granule micronize, make the microgranule 1 of magnitude range at the 1-50 micron;
Two, with microgranule 1 and pharmaceutic adjuvant uniform mixing, direct compression makes slow releasing tablet; If needed can be with the slow releasing tablet coating;
Perhaps, with microgranule 1 and pharmaceutic adjuvant uniform mixing, wet method prepares granule, drying; Pulverize; Be pressed into slow releasing tablet; If needed can be with the slow releasing tablet coating;
Pharmaceutic adjuvant described here can be any one or a few in starch, lactose, microcrystalline Cellulose, cellulosic polymer, polyvinyl pyrrole Lip river alkane ketone, calcium salt, alginate, the acrylate polymer;
Starch described here can be corn starch or modified corn starch;
Cellulosic polymer described here can be any one or a few in methylcellulose, hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, carboxymethyl cellulose, the carboxyethyl cellulose.
2, by the described method of claim 1, it is characterized in that the granulation liquid of wet granulation in the step 1, can adopt water; Or adopt that to contain the alcohol amount be the alcohol-water solution of 5-50%.
3, by claim 1 or 2 described methods, it is characterized in that the pharmaceutic adjuvant described in the step 1 is a polyvinyl pyrrole Lip river alkane ketone.
4, by claim 1 or 2 described methods, it is characterized in that the pharmaceutic adjuvant described in the step 1 is the mixture of polyvinyl pyrrole Lip river alkane ketone and lactose; Or the mixture of polyvinyl pyrrole Lip river alkane ketone and starch.
5, by claim 1 or 2 described methods, it is characterized in that the pharmaceutic adjuvant described in the step 1 is a hydroxypropyl cellulose; Or hydroxypropyl emthylcellulose.
6, by claim 1 or 2 described methods, it is characterized in that the pharmaceutic adjuvant described in the step 2 can be any one or a few in methylcellulose, hydroxy methocel, hydroxyethyl-cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, carboxymethyl cellulose and the carboxyethyl cellulose.
7, by the described method of claim 6, it is characterized in that the pharmaceutic adjuvant described in the step 2 is the mixture of hydroxypropyl cellulose and hydroxypropyl emthylcellulose.
8, by the described method of claim 6, it is characterized in that the pharmaceutic adjuvant described in the step 2 is a hydroxypropyl cellulose, or hydroxypropyl emthylcellulose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN95113357A CN1049114C (en) | 1995-12-07 | 1995-12-07 | Method for prepn. of slowly-released medicaments preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN95113357A CN1049114C (en) | 1995-12-07 | 1995-12-07 | Method for prepn. of slowly-released medicaments preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1151284A CN1151284A (en) | 1997-06-11 |
| CN1049114C true CN1049114C (en) | 2000-02-09 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN95113357A Expired - Fee Related CN1049114C (en) | 1995-12-07 | 1995-12-07 | Method for prepn. of slowly-released medicaments preparation |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100542528C (en) * | 2003-10-23 | 2009-09-23 | 中国医学科学院药物研究所 | Bicyclol micronization and controlled release formulations for oral administration |
| CN101966164A (en) * | 2010-07-28 | 2011-02-09 | 安徽永生堂药业有限责任公司 | Nifedipine sustained release tablet |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0385582A1 (en) * | 1989-02-14 | 1990-09-05 | Ethical Pharmaceuticals Limited | Nifedipine-containing pharmaceutical compositions and process for the preparation thereof |
| JPH0977978A (en) * | 1995-09-12 | 1997-03-25 | Shin Etsu Chem Co Ltd | Curable silicone elastomer composition and its production |
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1995
- 1995-12-07 CN CN95113357A patent/CN1049114C/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0385582A1 (en) * | 1989-02-14 | 1990-09-05 | Ethical Pharmaceuticals Limited | Nifedipine-containing pharmaceutical compositions and process for the preparation thereof |
| JPH0977978A (en) * | 1995-09-12 | 1997-03-25 | Shin Etsu Chem Co Ltd | Curable silicone elastomer composition and its production |
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| CN1151284A (en) | 1997-06-11 |
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